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NCT00544154 Clinical Trial

Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:
Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00544154
Other study ID # C87014
Secondary ID
Status Completed
Phase Phase 3
First received October 15, 2007
Last updated September 3, 2013
Start date October 2002
Est. completion date January 2004

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.

Recruitment information / eligibility
Status Completed
Enrollment 247
Est. completion date January 2004
Est. primary completion date January 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- male/female, 18-75 years old, inclusive

- diagnosis of adult-onset RA

- had active disease

- had received methotrexate

- on a stable dose of folic acid

Exclusion Criteria:

- contraindication for methotrexate or anti-TNF

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CDP870

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

References & Publications (1)

Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):12 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary American college of Rheumatolofy (ACR)-20 responder rate at Week 24
Secondary Safety and tolerability
Secondary health outcomes measures
Secondary immunogenic profile of CDP870 plus methotrexate
Secondary systemic exposure of CDP870
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